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Breast Cancer Risk Prediction by DL-based Phenotyping of Mammograms for Risk-Adjusted Screening (BEYOND DENSITY)

Breast Cancer Risk Prediction by DL-based Phenotyping of Mammograms for Risk-Adjusted Screening (BEYOND DENSITY) - BEYOND DENSITY

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036249
Enrollment
201780
Registered
2025-05-22
Start date
2025-06-19
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early detection of breast cancer through the mammography screening programme

Interventions

Group 1: In subprojects 1 and 2, at least 200,000 anonymised mammograms taken as part of the mammography screening programme are analysed retrospectively. In subproject 3, interviews are conducted wi

Sponsors

Uniklinik RWTH Aachen, Klinik für Diagnostische und Interventionelle Radiologie
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: In subproject 1+2: 1. Women did participate at German Mammography Screening in the past 2. Women were at least 50 years old at time of participation 3. Women did not have any clinical signs of breast cancer at time of screening 4. Follow-up information of at least two negative subsequent mammography screening rounds or cancer detection by a subsequent mammography screening or cancer detection outside the program In subproject 3: 1. Women currently participating in the mammogram screening programme in Germany

Exclusion criteria

Exclusion criteria: In subproject 1+2: 1. Women who have refused to report to the cancer registry In subproject 3: 1. Women who are not able to give consent 2. Women who are not able to take part in the structured interviews due to mental reasons

Design outcomes

Primary

MeasureTime frame
The aim of the study is to validate a novel deep learning algorithm that helps to identify women who have an increased risk of having a mammographically occult breast cancer, i.e. a risk of having a false-negative mammogram. The predictive power of the algorithm is compared with that of established risk prediction based on mammographically determined breast tissue density alone. By developing, calibrating and validating decision analytic modelling, the effectiveness, risk-benefit ratio and cost-effectiveness of different potential risk-adjusted screening methods for women at increased risk of breast cancer will be evaluated and compared.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026